Device recall
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
- Recall number
- Z-3209-2026
- Event id
- 99667
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Jul 31, 2026
- Center classification date
- Sep 16, 2026
- Product code
- LRO
- Device type
- General Surgery Tray
- Reason
- Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
- Root cause
- Under Investigation by firm
- Quantity
- 60
- Code info
- UDI-DI 10198459046551 Lot 25FBU754
- Distribution
- US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K213481
- Location
- Northfield, IL, United States